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NCT06222099 · ClinicalTrials.gov registry record · NA
The HEARTFELT Study
A NA study of Heart Failure and Chronic Heart Failure, sponsored by Heartfelt Technologies.
- Recruiting
- Registry status
- NA
- Development phase
- 1,500
- Enrollment target
- 3
- Study locations
NCT06222099: Recruiting NA study of Heart Failure and Chronic Heart Failure, sponsored by Heartfelt Technologies.
NCT06222099 is a NA study of Heart Failure and Chronic Heart Failure that is actively recruiting participants, run by Heartfelt Technologies. The registered enrollment target is 1,500 participants, below the 2,045-participant average among 397 other Heart Failure trials with a reported enrollment target (27% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06222099, a NA study of Heart Failure and Chronic Heart Failure, is actively recruiting participants, sponsored by Heartfelt Technologies.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,500 participants
- Enrollment target
- 3
- Study locations
Study Summary
This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce hospitalizations for the management of worsening HF (HF hospitalizations, HFHs) in nonadherent participants with chronic HF. The study objectives are: * Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs. * Secondary objectives: 1. Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices. 2. Establish the effect of the Heartfelt device on HF clinical outcomes. Participants will need to: * Install the device in their home for at least a year and up to 4 additional years after. * Reply to remote patient monitoring phone calls to follow the care plans.
Primary Outcome
Used to demonstrate whether the device effectively reduces HFHs and urgent HF visits.
Conditions Studied
Interventions
- OTHER Questionnaires
- OTHER Standard care
- DEVICE Heartfelt Device installed
- DEVICE Heartfelt-guided care
Study Locations (3)
Georgia
- Rimidi - Atlanta
New Jersey
- HealthArc - Hackensack
Pennsylvania
- Connect America - Bala-Cynwyd
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2025-10-23 |
| Est. Completion | 2030-12-31 |
| Phase | NA |
What NCT06222099 shows while recruiting
NCT06222099 is an interventional study that assigns participants to a tested intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, below the 2,045-participant average among 397 other Heart Failure trials with a reported enrollment target (27% lower).
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 4 interventions - of which Questionnaires is the first listed.
NCT06222099 reports a single indexed study location in Georgia, New Jersey, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06222099 about?
NCT06222099 is a clinical study titled "The HEARTFELT Study". This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to b...
What is the current status of trial NCT06222099?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,500 participants. The study started on 2025-10-23. Estimated completion is 2030-12-31.
What conditions does trial NCT06222099 study?
This clinical trial studies the following conditions: Heart Failure, Chronic Heart Failure.
What interventions are being tested in trial NCT06222099?
The interventions under investigation include: Questionnaires (OTHER), Standard care (OTHER), Heartfelt Device installed (DEVICE), Heartfelt-guided care (DEVICE).
Who is sponsoring clinical trial NCT06222099?
This trial is sponsored by Heartfelt Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06222099 being conducted?
This trial has 3 study locations across Georgia, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06222099's enrollment target sits among peer trials
1,500 54th of 397 higher than 340 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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